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A clinical trial to compare manually made kshar sutra with kshar sutra prepared by automated machine in patients having Fistula in Ano.

Double blind randomized comparative clinical evaluation of Kshara Sutra prepared manually and by Automated machine in Fistula-in-Ano (Bhagandara)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038414
Enrollment
100
Registered
2021-12-03
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K928- Other specified diseases of the digestive system

Interventions

Intervention1: automated kshara sutra (medicated thread): Kshar sutra ligation is a minimal invasive parasurgical procedure followed by internal administration of medicines and local application of me

Sponsors

CCRAS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients of either sex aged 18-60 years. 2.Confirmed case of fistula in ano. 3.Presence of any of the associated symptoms like Discharge, Pain, Tenderness, Itching, Induration / Swelling. 4.Willing and able to participate till the trial completes

Exclusion criteria

Exclusion criteria: 1.Patients aged 60 years. 2.Fistula connected with other organs like urethra, vagina etc. 3.Patients with malignancy 4.Tuberculosis/ uncontrolled Diabetes/ established Systemic diseases like Ulcerative colitis, Crohnââ?¬•s disease etc. 5.Bleeding diathesis. 6.Patients who have completed participation in any other clinical trial during the past six (06) months. 7.Any other condition which the Investigator thinks may jeopardize the study

Design outcomes

Primary

MeasureTime frame
Change in the Quality of Life (SF-36 Health Survey) ScoreTimepoint: At baseline, And after final thread cut out

Secondary

MeasureTime frame
Fistula cutting time through kshara sutra Validation of the ksharasutra prepared by the automated machine and establishment of the usefulness of the automated ksharasutra machine in comparision to the standard Ksharasutra manually prepared Timepoint: At baseline, and after final thread cut out

Countries

India

Contacts

Public ContactDr Hemanta Panigrahi

CARI

drhemanta71@gmail.com9968074400

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 12, 2026